Structuring involvement
Where do you start if you want to involve patients in your research? There is no set recipe for this. We can, however, point you in the right direction based on previous experiences, research projects and literature. There are preconditions, methods and principles that help in structuring patient involvement.
A step-by-step plan
The following steps will help you involve patients in your research meaningfully.
It is important to determine in advance what you want to achieve with patient involvement. What is your objective? This will determine which activities will generate the best results.
Patients can contribute to your research for a variety of reasons and in many ways. You can involve patients in your research to gather experiential accounts, for instance. In this case the patient is a source of information, who can shed more light on the disorder or into life as a patient.
Another objective is to get advice on your research. Patients have a more active role to play here. They have greater impact, but also more responsibility. This could be in a steering committee with patients, for instance. The added value of involvement lies in, for example, a research design that is more in line with what patients want.
The Involvement Ladder (in Dutch) will help you determine your objective. The ladder provides an understanding of the roles that patients can fulfil and the contribution that they can make:
- sharing needs and experiences
- contributing ideas
- providing advice
- testing/assessing
- co-producing
The video below provides more information on the Involvement Matrix (in Dutch):
Or see a few practical examples that show how patient involvement can contribute to the quality of research (in Dutch).
The various roles that patients can fulfil in your study require them to have specific knowledge, skills and experience. The selection of the appropriate expert by experience is closely related to your objective (see Step 1).
Giving an experiential account, for example, is very different from participating in a steering committee. It is therefore important to determine in advance what you expect of a patient representative. If, for example, only an experiential account is involved, then expertise by experience is sufficient and the educational background of the patient does not matter. In addition, being able to represent others would then not be important.
If you want a patient representative on the steering committee, then the intended patient must have more knowledge of research and be able to represent others. The ‘Finding the appropriate expert by experience‘ section of the Kickstarter will help you find a suitable patient.
Take into account who you involve and how you will adapt your activities accordingly. Many patients have a lower energy level, for instance. If you involve these patients, they may have to adjust their entire daily routine. An appointment at 9 a.m. is not feasible for everyone because some patients depend on home care, need time to get going in the mornings or rely on a taxi to get them to the location. The accessibility of the location or the layout of a room can also be a factor. Poor accessibility by public transportation, long distances (also within a building itself) or stairs can be an obstacle. Carpeting on the floor, for example, is not pleasant for people with Parkinson’s disease or asthma.
Patients’ contribution is useful in every research phase – when determining the research question, when writing the research proposal, when collecting data and during analysis and dissemination.
Involve patients as early as possible, preferably during the idea and planning phase. This will often generate surprising perspectives, choices, priorities and the best results. The overview below will lead you to the possibilities in each research phase.
You can involve patients in different ways within each research phase. The method that you choose will depend on the purpose of the involvement. If you only wish to consult patients, you will select a different method than if you wish to enter into a partnership. There are more options than just interviews and focus groups.
If you want to consult patients, for example, you can consider:
- interviews
- a patient diary
- observations
- an online or in person focus group
- an Open Space meeting
- a survey
- a Delphi study
To obtain advice from patients, you can make use of:
- patient panels
- patient/client councils
- including patients in working groups
If there are no patient panels yet for your research topic, then you might consider setting one up in collaboration with a patient organisation.
An example of a patient advisory committee is PARTNER, which was set up in the Neurology department of Radboud UMC. The patients on this committee help to improve scientific research on their own disorder.
And for collaboration with patients, you can:
- include them in a project group
- involve them as co-researcher
- involve them via experience-based co-design (in Dutch)
Select a research phase:
- Specifying research questions (in Dutch)
- Writing a research proposal (in Dutch)
- Data collection (in Dutch)
- Analysis and dissemination (in Dutch)
Evaluate
On completion, evaluate whether involvement has been good. And remember also to do this during the course of the project. When is patient involvement satisfactory? That depends on your objective (see Step 1). And also on what you are considering: the process and/or the results. A fair amount of research has already been carried out on the process of patient involvement, but not as much on its effectiveness.
An evaluation tool for patient involvement in medicines research and development is available.
Furthermore, consensus has been reached on 9 recommendations for the successful involvement of patients/clients in medical research (in Dutch) by 20 patient organisations.
Give feedback
It is essential to keep in touch with the involved patients and provide them with feedback on what has been done with their input. It is very frustrating to have invested time and energy in something only never to hear anything more about it. However, you do not have to share everything immediately, although it is important to explain why certain input was not used.
Publish
If you involve patients in your research correctly, you will gain more support from patients while stakeholders will rate your research more highly. We therefore recommend publishing the research. The British Medical Journal (BMJ) even requires to mention how patients were involved.
Give patients a role in your publications. Involve a patient as author or co-author or present your results together at a conference.
WECAN and Envision Pharma Group developed 4 online modules on being an author, co-author or peer-reviewer.
Be inspired by the research publication Tackle your Tics, of which an expert by experience was a co-author.
Describing the type of participatory research used reduces the risk of pseudo-participation and can encourage other researchers to integrate patient involvement in their research.
An example
Patients of the Parkinson’s Association recently co-authored several articles. In addition to being co-authors, they were also involved throughout the research at various points in time and in several ways as patient researchers.
- (2015) BEWARE: Body awareness training in the treatment of wearing-off related anxiety in patients with Parkinson’s disease: study protocol for a randomized controlled trial.
- (2017) Body awareness training in the treatment of wearing-off related anxiety in patients with Parkinson’s disease: Results from a pilot randomized controlled trial.
- (2019) Dementia and Parkinson’s Disease: Similar and Divergent Challenges in Providing Palliative Care.
Focus on type and content
Sometimes describing patients’ contribution in detail is unnecessary, for example in publications on fundamental research, methodology or statistics. It is paramount that the way the information is published is discussed between the researcher and the patient representative, preferably from the start of the research.
Always guarantee the anonymity of the patient representatives involved, unless otherwise agreed upon. Furthermore, it is recommended that you publish in non-scientific media and in understandable language, using lay summaries and videos for instance. Again, mention that patients were involved.
The first international guideline for publishing patient involvement in social care and healthcare, the GRIPP2 reporting checklist, can be helpful.
Preconditions
Enter into and maintain a dialogue and discuss the collaboration. Start with a good initial meeting.
Determine whether a patient representative requires training or ask the representative whether they feel they require this.
INVOLV offers a range of training courses for patient representatives in scientific research (in Dutch).
Be aware of the balance of power between patient and researcher:
- Create an equal footing
- It is preferable not to include your own patients in the research population, unless you have no other option (in the case of rare disorders, for instance). Also see the Kickstarter section: Finding the appropriate expert by experience.
Take into account a financial allowance for patients.
Requesting input from patients requires you to assess the input received seriously. Be open to their input and communicate clearly what you will do with it or why you will not use it.
INVOLV provides advice and support on patient involvement in scientific research to researchers, research institutions and patient representatives (in Dutch).